Allergy Therapeutics shares plunge after disappointing clinical trial

By Josh White

Date: Monday 18 Mar 2019

Allergy Therapeutics shares plunge after disappointing clinical trial

(Sharecast News) - Shares in biotechnology company Allergy Therapeutics were plunging on Monday morning, after it announced disappointing top-line results from the phase 3 clinical trial 'B301' of its new adjuvanted birch allergoid product.
The AIM-traded firm said the trial did not show a statistically significant difference between active and placebo arms in the primary endpoint of a combined symptom medication score averaged over the peak birch pollen season.

It said the safety and tolerability profile was positive and consistent with that observed in previous trials.

The company also noted that secondary endpoint analyses of immunoglobulin markers, including IgG and IgG4, showed "highly statistically significant" differences between active and placebo, suggesting a strong and sustained immune response to treatment.

"We are surprised by the result, given the strong immune response suggested by the increased immunoglobulin markers in the treatment arm and the substantial symptom improvement we had observed in earlier trials," said Allergy Therapeutics chief executive officer Manuel Llobet.

"We will now undertake a comprehensive review of the full dataset to determine our path forward with the investigational product."

Llobet said that, as a science-driven company, the board was conscious of the challenges regarding subjective measures in allergy field studies.

"We are committed to overcoming these challenges and bringing this new product to market."

Allergy Therapeutics said that since 2010, the investigational product had undergone two successful phase 3 trials where a highly statistically significant 32% reduction in allergic symptoms between the active and placebo was observed.

The group would now undertake a review of the full trial dataset to understand any cause for the lack of consistency in the clinical outcomes seen between the studies.

It explained that the B301 trial was a multi-centre, double-blind, placebo-controlled study designed to test the efficacy in birch-pollen induced seasonal allergic rhinitis.

The European study took place in Germany, Poland, Austria and Sweden with 582 patients over 59 centres being randomised into active and placebo arms, to evaluate the safety and efficacy measured as a reduction in allergic symptoms as determined by the combined symptom medication score.

As at 1109 GMT, shares in Allergy Therapeutics were down 43.58% at 8.12p.


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